A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576199
First received: December 18, 2007
Last updated: August 18, 2014
Last verified: August 2014
Results First Received: August 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Cancer
Interventions: Drug: Bevacizumab
Procedure: Transarterial chemoembolisation (TACE)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Participant Flow data are discontinuations from bevacizumab treatment. Data for discontinuations from the study are not available.

Reporting Groups
  Description
Bevacizumab 5 mg/kg Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.

Participant Flow:   Overall Study
    Bevacizumab 5 mg/kg  
STARTED     30  
COMPLETED     0  
NOT COMPLETED     30  
Adverse Event                 12  
Insufficient Therapeutic Response                 14  
Refused Treatment                 2  
Reason Unspecified                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: All participants who received study medication.

Reporting Groups
  Description
Bevacizumab 5 mg/kg Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.

Baseline Measures
    Bevacizumab 5 mg/kg  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean ± Standard Deviation
  62.8  ± 10.43  
Gender  
[units: participants]
 
Female     4  
Male     26  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

2.  Secondary:   Percentage of Participants With an Objective Response   [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

3.  Secondary:   Time to Progression   [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

4.  Secondary:   Overall Survival   [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

5.  Secondary:   Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease   [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

6.  Secondary:   Tumor Necrosis   [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576199     History of Changes
Other Study ID Numbers: ML21358
Study First Received: December 18, 2007
Results First Received: August 18, 2014
Last Updated: August 18, 2014
Health Authority: Hong Kong: Department of Health